Affimed N.V. announced the publication of a manuscript that demonstrates how the FcRn-pH-HPLC technology can be leveraged to predict PK properties of various ICE®? formats built on the ROCK®? platform.

PK parameters - such as half-life - impact the efficacy, tolerability, dose, and administration schedule of therapeutic antibodies. Identification of antibody candidates with optimal PK properties can therefore inform on the antibody with the best clinical developability. The PK profiles of therapeutic antibodies in vivo are largely governed by their pH-dependent binding to the human neonatal Fc receptor, FcRn.

In the presented study, the FcRn-HPLC methodology has been further optimized by coupling it to a pH monitor and determining the pH of FcRn dissociation of antibodies, thus providing a potential surrogate assay for estimating in vivo serum half-lives. Leveraging the FcRn-pH-HPLC revealed that the antibody architecture, e.g. sequence of antigen-binding domains, as well as number, structure, and orientation of these domains significantly alters the FcRn dissociation pH. Certain antibody structures are therefore predicted to have better PK properties in vivo than others.